(69 days)
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Isolite® Earloop Face Masks Blue, Pink .
- Crosstex® Isofluid® Earloop Face Masks Blue, Pink, White, Green .
- Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
- Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
- . Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue .
- Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor Blue ●
The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of tissue or 100% spunbonded polypropylene, a 100% meltblown polypropylene filter media, with white elastic loops and/or a fogfree strip. The nose piece for all seven (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).
This 510(k) summary (K082258) describes the Crosstex® Surgical Masks. The document does not describe an AI/ML device, and therefore the standard questions about acceptance criteria, study design, and ground truth for such a device are not applicable.
The submission is for surgical masks and primarily relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices.
Here's the information as it relates to the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance (Liquid (Water) Resistance Test/Impact Penetration Test) | Not explicitly stated, implied to meet requirements of "relevant test standards" | "Performance Testing met all relevant requirements of the aforementioned test standards." |
| Bacterial Filtration Efficiency (BFE) | Not explicitly stated, implied to meet requirements of "relevant test standards" | "Performance Testing met all relevant requirements of the aforementioned test standards." |
| Differential Pressure (△P) | Not explicitly stated, implied to meet requirements of "relevant test standards" | "Performance Testing met all relevant requirements of the aforementioned test standards." |
| Flammability Testing | Not explicitly stated, implied to meet requirements of "relevant test standards" | "Performance Testing met all relevant requirements of the aforementioned test standards." |
| Latex Particle Challenge Test | Not explicitly stated, implied to meet requirements of "relevant test standards" | "Performance Testing met all relevant requirements of the aforementioned test standards." |
| Biocompatibility Testing (Per ISO 10993) | Not explicitly stated, implied to meet requirements of "relevant test standards" | "Performance Testing met all relevant requirements of the aforementioned test standards." |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "Performance Testing" but does not detail the specific sample sizes used for each test or the provenance of the test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the device is not an AI/ML diagnostic tool that requires expert-established ground truth from a test set. The evaluation is based on objective physical and biological performance tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of human adjudication in the context of establishing ground truth for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is not an AI/ML system and therefore no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the results of standardized laboratory performance tests (e.g., BFE, fluid resistance, flammability) against established benchmarks or predicate device performance. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.
8. The sample size for the training set
This is not applicable as there is no AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML model that requires a training set.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.